Transcript Optimizing Data Standards Working Group

Optimizing Data Standards
Working Group
Meeting Summary
2014-04-18
Optimizing Data Standards
• Meeting Summary
– Break out sessions for each working group
• Traceability and Data Flow
• ADaM Data Reviewer’s Guide
• Best Practices (New: Multiple Sub-Projects Identified)
– Identified new project to be initiated following this
meeting:
• Study Data Standardization Plan (SDSP)
Optimizing Data Standards
Active Projects
Traceability and
Data Flow
ADaM Data
Reviewer’s
Guide
Best Practices
Study Data
Standardization
Plan
ODS Projects
Traceability and Data Flow
• Leaders: Paul Bukowiec, Sandra Minjoe, Tanja
Petrowitsch, Natalie Reynolds
• This project will discuss and define traceability
considerations and best practices for study level
dataset and integrated datasets conversion for a
variety of different data flow scenarios.
ODS Projects
Traceability and Data Flow
• Meeting Accomplishments:
– Developed first draft of Study Level Traceability
white paper
– Noted specific traceability details to be added to
current Basic Linear Data Flow white paper
– Determined the need to develop a template for the
Legacy Data Conversion Plan (mentioned in the new
draft FDA Study Data Technical Conformance Guide)
ODS Projects
Traceability and Data Flow
• Next Steps:
– Scoped 4 tasks, assigned leads and members
1. Update Basic Linear Data Flow white paper
2. Finalize Study Level Traceability white paper
3. Develop Integration Level Traceability white
paper
4. Develop Legacy Data Conversion Plan Template
– Developed draft timelines and meeting plans
ODS Projects
Analysis Data Reviewer’s Guide (ADRG)
• Leaders: Susan Kenny, Gail Stoner
• Development of an ADRG template and instructions for
industry to consider that will enable consistent and
usable ADaM documentation in submissions.
ODS Projects
Analysis Data Reviewer’s Guide (ADRG)
• Accomplished at Meeting
– Completed final review of Template
– Completed final review of Completion Guideline
– Presented poster and expect to receive additional
comments. Comments due by MARCH 28.
– Began review of one ADRG example
• By April 30:
– Complete review and updates to 2 examples
– Finalize ALL documents (template, guidelines, samples)
– Post all materials to PhUSE Wiki
ODS Projects
Best Practices for Standards Implementation (NEW)
– Leaders: Mike Molter, Lisa Lyons
– Goal of the Project is to develop a set of
recommendations for best practices in optimizing the
data standards. Short, single topic best practice
recommendations available on the Wiki.
– Each topic will be ~3-5 months duration for delivery of
the recommendation.
– Each best practice will have a sub-team (with
leadership) under the Best Practices leadership to
address each topic.
Data Optimization: Best Practices
• What: Lab Unit Standardization
• Leader: Mat Bryant
• Description: Challenges of defining an
industry wide standard unit (e.g. --STRESU).
Also to include…
• LB SDTM domain, 50-100 tests,
• Dimension representation of standard
units (e.g. mg vs Mg)
• Need an EU member – Contact Mat
Data Optimization: Best Practices
• What: EPOCH/VISITNUM Assignments
• Leader: Natalia Smeljenski
• Description: Challenges of defining, deriving,
and implementing assignment of values of
these variables at a subject level
Data Optimization: Best Practices
• What: Multiple Imputation Data Sets
• Leader: Robert Woolson
• Description: Addresses the use of stepwise
multiple imputation data sets
• Note: This topic will be addressed within
the CDISC ADaM team.
Data Optimization: Best Practices
• What: USUBJID Assignment
• Leaders: Monica Mattson, Mark Sullivan
• Description: Assignment of values to
USUBJID to ensure uniqueness across an
application and within study.
Data Optimization: Best
Practices
• Future Best Practices Topics Identified
– Programming Documentation
– Reference Range Standardization
– Unit Standardization Beyond Labs
– Trial Design Setup
– Treatment Emergent Flags
– ARM/ARMCD assignment and standard implementation
– Others welcome – Will be a place to identify new topics
on Best Practices Wiki
ODS Project
• Study Data Standardization Plan (SDSP)
– New Project Starting in 2014
– Goal of the Project is to develop a Template to be made
available for Industry to Use.
– Template Model will follow a similar development as the
SDTM and ADaM Reviewer’s Guide
– Initial Leads: Jane Lozano, Jim Johnson
• 16 people (Industry and FDA) have indicated interest to
participate.
– Teleconference and Initial Meeting will be in April 2014
– Initial Goal is to have a Template Available by PhUSE
Meeting (October 2014)
ODS Project
• Study Data Standardization Plan (SDSP) (Cont’D)
– Initial discussion of the SDSP indicates that the
template may address:
• Non-clinical (SEND) data – Will reach out to Non-Clinical
team for representation on SDSP team
• Should consider including endpoints relevant to the data
standardization.
• Template should be organic and grow with the program as
new information is developed with the CDP.
• SDSP may be an Appendix (Attachment) to the Clinical
Development Plan
Optimizing Data Standards
Thank You